BioCentury
ARTICLE | Clinical News

Eteplirsen regulatory update

January 25, 2016 8:00 AM UTC

FDA postponed a Jan. 22 meeting of its Peripheral and Central Nervous System Drugs Advisory Committee to discuss an NDA for eteplirsen from Sarepta to treat Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping, citing forecasts of inclement weather in Washington, D.C. The agency said it will announce a new date in the Federal Register. ...